Establishment Standards for Veterinary Drugs Manufacturers Article 6
There shall be separated independent plants equipped with independent air treatment systems where the veterinary biomedicines or biotechnical products are manufactured along with other medications or sanitary agents of the same manufacturer.There shall be at least 8 meters between the manufacture, processing and packaging workplaces and starting materials warehouse of the sanitary agents and the exterior of those of the veterinary drugs. The workplaces and facilities of the veterinary and human-use drugs shall be separated and may not be in the same building with no segmentation. However, this does not apply to any manufacturer that employs the standards conforming to the veterinary drugs to manufacture the medications for human use.
中文原文 動物用藥品製造廠設廠標準第6條
製造動物用生物藥品或生物技術產品兼製其他藥品或環境衛生用藥者,應有具隔離效果之獨棟廠房,及各自獨立之空氣處理系統。
藥廠兼製環境衛生用藥者,其環境衛生用藥製造、加工、分裝作業場所及原料倉庫,應與動物用藥品製造、加工、分裝作業場所外圍保持八公尺以上之距離。
藥廠與製造人用藥品之場所、設備,均應分開,不得在未隔絕之同一建築物作業。
但使用符合動物用藥品規格製造人用藥品者,不在此限。
藥廠兼製環境衛生用藥者,其環境衛生用藥製造、加工、分裝作業場所及原料倉庫,應與動物用藥品製造、加工、分裝作業場所外圍保持八公尺以上之距離。
藥廠與製造人用藥品之場所、設備,均應分開,不得在未隔絕之同一建築物作業。
但使用符合動物用藥品規格製造人用藥品者,不在此限。